Original Investigation
Patient-Reported Outcome Measures for Fatigue in Patients on Hemodialysis: A Systematic Review

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Background

Fatigue is a prevalent and debilitating symptom in patients receiving hemodialysis. We aimed to identify and evaluate the characteristics and psychometric properties of patient-reported outcome measures for fatigue in patients receiving hemodialysis, to inform the selection of a robust and feasible measure for use in randomized trials in hemodialysis.

Study Design

Systematic review of outcome measures for fatigue.

Setting & Population

Patients receiving hemodialysis.

Search Strategy & Sources

MEDLINE, Embase, PsycINFO, and CINAHL from inception to April 2017 were searched for all studies that reported fatigue in patients receiving hemodialysis.

Analytical Approach

With a focus on addressing methods, items (individual questions) from all measures were categorized into content and measurement dimensions of fatigue. We assessed the general characteristics (eg, number of items and cost) and psychometric properties of all measures.

Results

From 123 studies, we identified 43 different measures: 24 (55%) were developed specifically for the hemodialysis population (of which 18 were nonvalidated author-developed measures for use in their study only), 17 (40%) for other populations, and 2 (5%) for chronic kidney disease (all stages). The measures assessed 11 content dimensions of fatigue, the 3 most frequent being level of energy (19 [44%]), tiredness (15 [35%]), and life participation (14 [33%]); and 4 measurement dimensions: severity (34 [79%]), frequency (10 [23%]), duration (4 [9%]), and change (1 [2%]). The vitality subscale of the 36-Item Short Form Health Survey (SF-36) was the most frequently used (19 [15%] studies), but has only been tested for reliability in hemodialysis. Of the fatigue-specific measures, the Chalder Fatigue Scale was the only one evaluated in hemodialysis, but the full psychometric robustness remains uncertain.

Limitations

For feasibility, we searched for validation studies in the hemodialysis population using the names of measures identified in the primary search strategy.

Conclusions

A very wide range of measures have been used to assess fatigue in patients receiving hemodialysis, each varying in content and length. Many have limited validation data available in this population. A standardized and psychometrically robust measure that captures dimensions of fatigue that are important to patients is needed to estimate and improve this disabling complication of hemodialysis.

Section snippets

Selection Criteria

Based on a preliminary search for clinical trials reporting fatigue in patients receiving hemodialysis that yielded very few studies and a small range of measures, we broadened the inclusion criteria to all study designs (randomized, nonrandomized,7 and descriptive studies8) that involved adult patients (aged ≥18 years) on maintenance hemodialysis therapy (for ≥90 days) and reported at least one measure of fatigue. Studies published in peer-reviewed journals were included; unpublished studies

Characteristics of Studies

Of 3,110 references identified, 140 eligible studies involving more than 24,800 participants receiving hemodialysis (2 studies did not report the number of participants) across 31 countries were included. These included 18 (13%) randomized controlled trials, 24 (17%) nonrandomized controlled trials, and 98 (70%) observational studies. Search results can be found in Figure 1. Study characteristics are shown in Item S1.

Characteristics of the Measures

Across the 140 studies, 45 different measures were used to measure fatigue. Of

Discussion

Our analysis of 140 studies revealed that a very wide range of nonvalidated measures have been used to assess fatigue in patients receiving hemodialysis, and none appear to be fit for the purpose in this setting. Of the 45 different measures identified, only 24 (53%) were specifically designed for use in the hemodialysis population. Nineteen of these hemodialysis-specific measures were developed for single use in the author’s study without formal validation. The 45 measures varied in complexity

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    Authors’ Full Names and Academic Degrees: Angela Ju, BSc (Hons), Mark L. Unruh, MD, Sara N. Davison, MD, PhD, Juan Dapueto, PhD, Mary Amanda Dew, PhD, Richard Fluck, FRCP, Michael Germain, MD, Sarbjit Vanita Jassal, MD, Gregorio Obrador, MD, Donal O’Donoghue, FRCP, Peter Tugwell, PhD, Jonathan C. Craig, PhD, Angelique F. Ralph, BPsych (Hons), Martin Howell, PhD, and Allison Tong, PhD.

    Authors’ Contributions: Research idea and study design: all authors; data acquisition: AJ, AFR, AT; data analysis /interpretation: all authors; supervision or mentorship: AT, JCC. Each author contributed important intellectual content during manuscript drafting or revision and accepts accountability for the overall work by ensuring that questions pertaining to the accuracy or integrity of any portion of the work are appropriately investigated and resolved.

    Support: Dr Tong is supported by a National Health and Medical Research Council fellowship (1106716). The funding organization had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

    Financial Disclosure: The authors declare that they have no relevant financial interests.

    Peer Review: Received January 18, 2017. Evaluated by 3 external peer reviewers, with direct editorial input from a Statistics/Methods Editor, an Associate Editor, and the Editor-in-Chief. Accepted in revised form August 10, 2017.

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    © 2017 by the National Kidney Foundation, Inc.